JPWO2020106522A5 - - Google Patents

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JPWO2020106522A5
JPWO2020106522A5 JP2021529104A JP2021529104A JPWO2020106522A5 JP WO2020106522 A5 JPWO2020106522 A5 JP WO2020106522A5 JP 2021529104 A JP2021529104 A JP 2021529104A JP 2021529104 A JP2021529104 A JP 2021529104A JP WO2020106522 A5 JPWO2020106522 A5 JP WO2020106522A5
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rofecoxib
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JP2022508200A (en
JP7291220B2 (en
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Priority claimed from PCT/US2019/061178 external-priority patent/WO2020106522A1/en
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高純度ロフェコキシブまたはその薬学的に許容し得る塩、および薬学的に許容し得る担体を含む、医薬組成物であって、
高純度ロフェコキシブが、０．１０％未満の総不純物を含む、前記医薬組成物。 A pharmaceutical composition comprising highly pure rofecoxib or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier,
Said pharmaceutical composition, wherein the highly pure rofecoxib contains less than 0.10% total impurities. 高純度ロフェコキシブが、４－［４－（メチルスルホニル）フェニル］－３－フェニル－２，５－フランジオンを含まない、請求項１に記載の医薬組成物。 2. The pharmaceutical composition according to claim 1, wherein the high purity rofecoxib is free of 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2,5-furandione. 高純度ロフェコキシブが、０．１０％未満の４－［４－（メチルチオ）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項１に記載の医薬組成物。 2. The pharmaceutical composition of claim 1, wherein the highly pure rofecoxib contains less than 0.10% 4-[4-(methylthio)phenyl]-3-phenyl-2(5H)-furanone. 高純度ロフェコキシブが、０．１０％未満の４－［４－（メチルスルフィニル）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項１に記載の医薬組成物。 2. The pharmaceutical composition of claim 1, wherein the high purity rofecoxib contains less than 0.10% 4-[4-(methylsulfinyl)phenyl]-3-phenyl-2(5H)-furanone. １２．５ｍｇ、１７．５ｍｇ、または２０ｍｇの高純度ロフェコキシブまたはその薬学的に許容し得る塩、および薬学的に許容し得る担体を含む、医薬組成物であって、
高純度ロフェコキシブが、０．１０％未満の総不純物を含む、前記医薬組成物。 A pharmaceutical composition comprising 12.5 mg, 17.5 mg, or 20 mg of highly purified rofecoxib or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier,
Said pharmaceutical composition, wherein the highly pure rofecoxib contains less than 0.10% total impurities. 高純度ロフェコキシブが、４－［４－（メチルスルホニル）フェニル］－３－フェニル－２，５－フランジオンを含まない、請求項５に記載の医薬組成物。 6. The pharmaceutical composition according to claim 5, wherein the high purity rofecoxib is free of 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2,5-furandione. 高純度ロフェコキシブが、０．１０％未満の４－［４－（メチルチオ）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項５に記載の医薬組成物。 6. The pharmaceutical composition according to claim 5, wherein the high-purity rofecoxib contains less than 0.10% 4-[4-(methylthio)phenyl]-3-phenyl-2(5H)-furanone. 高純度ロフェコキシブが、０．１０％未満の４－［４－（メチルスルフィニル）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項５に記載の医薬組成物。 6. The pharmaceutical composition according to claim 5, wherein the high-purity rofecoxib contains less than 0.10% 4-[4-(methylsulfinyl)phenyl]-3-phenyl-2(5H)-furanone. ヒト対象への経口、経鼻、吸入、局所、頬側、舌下、直腸、膣、および非経口の投与のうちの１つ以上に適している、請求項１に記載の医薬組成物。 2. The pharmaceutical composition of claim 1, suitable for one or more of oral, nasal, inhalational, topical, buccal, sublingual, rectal, vaginal, and parenteral administration to a human subject. ヒト対象への経口投与に適している、請求項９に記載の医薬組成物。 10. The pharmaceutical composition of claim 9, suitable for oral administration to human subjects. ロフェコキシブが、１０～１２μｍのｄ９０粒子サイズ、３～４μｍのｄ５０粒子サイズ、および０．５～１．０μｍのｄ１０粒子サイズを有する、請求項１に記載の医薬組成物。 2. The pharmaceutical composition of claim 1, wherein rofecoxib has a d90 particle size of 10-12 μm, a d50 particle size of 3-4 μm, and a d10 particle size of 0.5-1.0 μm. ヒト対象への経口、経鼻、吸入、局所、頬側、舌下、直腸、膣、および非経口の投与のうちの１つ以上に適している、請求項５に記載の医薬組成物。 6. The pharmaceutical composition of claim 5, suitable for one or more of oral, nasal, inhalational, topical, buccal, sublingual, rectal, vaginal, and parenteral administration to a human subject. ヒト対象への経口投与に適している、請求項１２に記載の医薬組成物。 13. The pharmaceutical composition of claim 12, suitable for oral administration to human subjects. ロフェコキシブが、１０～１２μｍのｄ９０粒子サイズ、３～４μｍのｄ５０粒子サイズ、および０．５～１．０μｍのｄ１０粒子サイズを有する、請求項５に記載の医薬組成物。 6. The pharmaceutical composition of claim 5, wherein rofecoxib has a d90 particle size of 10-12 μm, a d50 particle size of 3-4 μm, and a d10 particle size of 0.5-1.0 μm. ロフェコキシブまたはその薬学的に許容し得る塩、および薬学的に許容し得る担体を含む、医薬組成物であって、
ロフェコキシブまたはその薬学的に許容し得る塩が、０．０５％未満の４－［４－（メチルスルホニル）フェニル］－３－フェニル－５－ヒドロキシフラン－２－オンを含み、ロフェコキシブまたはその薬学的に許容し得る塩が、０．１０％未満の総不純物を含む、前記医薬組成物。 A pharmaceutical composition comprising rofecoxib or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier,
rofecoxib or a pharmaceutically acceptable salt thereof containing less than 0.05% 4-[4-(methylsulfonyl)phenyl]-3-phenyl-5-hydroxyfuran-2-one; said pharmaceutical composition, wherein said acceptable salt contains less than 0.10% total impurities. ロフェコキシブまたはその薬学的に許容し得る塩が、４－［４－（メチルスルホニル）フェニル］－３－フェニル－５－ヒドロキシフラン－２－オンを含まない、請求項１５に記載の医薬組成物。 16. The pharmaceutical composition according to claim 15, wherein rofecoxib or a pharmaceutically acceptable salt thereof is free of 4-[4-(methylsulfonyl)phenyl]-3-phenyl-5-hydroxyfuran-2-one. ロフェコキシブまたはその薬学的に許容し得る塩が、４－［４－（メチルスルホニル）フェニル］－３－フェニル－２，５－フランジオンを含まない、請求項１５に記載の医薬組成物。 16. The pharmaceutical composition according to claim 15, wherein rofecoxib or a pharmaceutically acceptable salt thereof is free of 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2,5-furandione. ロフェコキシブまたはその薬学的に許容し得る塩が、０．１０％未満の４－［４－（メチルチオ）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項１５に記載の医薬組成物。 16. The pharmaceutical composition according to claim 15, wherein rofecoxib or a pharmaceutically acceptable salt thereof contains less than 0.10% 4-[4-(methylthio)phenyl]-3-phenyl-2(5H)-furanone. thing. ロフェコキシブまたはその薬学的に許容し得る塩が、０．１０％未満の４－［４－（メチルスルフィニル）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項１５に記載の医薬組成物。 16. The medicament according to claim 15, wherein rofecoxib or a pharmaceutically acceptable salt thereof contains less than 0.10% 4-[4-(methylsulfinyl)phenyl]-3-phenyl-2(5H)-furanone. Composition. ヒト対象への経口、経鼻、吸入、局所、頬側、舌下、直腸、膣、および非経口の投与のうちの１つ以上に適している、請求項１５に記載の医薬組成物。 16. The pharmaceutical composition of claim 15, suitable for one or more of oral, nasal, inhalational, topical, buccal, sublingual, rectal, vaginal, and parenteral administration to a human subject. ヒト対象への経口投与に適している、請求項２０に記載の医薬組成物。 21. The pharmaceutical composition of claim 20, suitable for oral administration to human subjects. ロフェコキシブまたはその薬学的に許容し得る塩が、１０～１２μｍのｄ９０粒子サイズ、３～４μｍのｄ５０粒子サイズ、および０．５～１．０μｍのｄ１０粒子サイズを有する、請求項１５に記載の医薬組成物。 16. The medicament of claim 15, wherein rofecoxib or a pharmaceutically acceptable salt thereof has a d90 particle size of 10-12 μm, a d50 particle size of 3-4 μm, and a d10 particle size of 0.5-1.0 μm. Composition. １２．５ｍｇ、１７．５ｍｇ、または２０ｍｇのロフェコキシブまたはその薬学的に許容し得る塩、および薬学的に許容し得る担体を含む、医薬組成物であって、
ロフェコキシブまたはその薬学的に許容し得る塩が、０．０５％未満の４－［４－（メチルスルホニル）フェニル］－３－フェニル－５－ヒドロキシフラン－２－オンを含み、ロフェコキシブまたはその薬学的に許容し得る塩が、０．１０％未満の総不純物を含む、前記医薬組成物。 A pharmaceutical composition comprising 12.5 mg, 17.5 mg, or 20 mg of rofecoxib or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier,
rofecoxib or a pharmaceutically acceptable salt thereof containing less than 0.05% 4-[4-(methylsulfonyl)phenyl]-3-phenyl-5-hydroxyfuran-2-one; said pharmaceutical composition, wherein said acceptable salt contains less than 0.10% total impurities. ロフェコキシブまたはその薬学的に許容し得る塩が、４－［４－（メチルスルホニル）フェニル］－３－フェニル－５－ヒドロキシフラン－２－オンを含まない、請求項２３に記載の医薬組成物。 24. The pharmaceutical composition according to claim 23, wherein rofecoxib or a pharmaceutically acceptable salt thereof is free of 4-[4-(methylsulfonyl)phenyl]-3-phenyl-5-hydroxyfuran-2-one. ロフェコキシブまたはその薬学的に許容し得る塩が、４－［４－（メチルスルホニル）フェニル］－３－フェニル－２，５－フランジオンを含まない、請求項２３に記載の医薬組成物。 24. The pharmaceutical composition according to claim 23, wherein rofecoxib or a pharmaceutically acceptable salt thereof is free of 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2,5-furandione. ロフェコキシブまたはその薬学的に許容し得る塩が、０．１０％未満の４－［４－（メチルチオ）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項２３に記載の医薬組成物。 24. The pharmaceutical composition according to claim 23, wherein rofecoxib or a pharmaceutically acceptable salt thereof contains less than 0.10% 4-[4-(methylthio)phenyl]-3-phenyl-2(5H)-furanone. thing. ロフェコキシブまたはその薬学的に許容し得る塩が、０．１０％未満の４－［４－（メチルスルフィニル）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項２３に記載の医薬組成物。 24. A medicament according to claim 23, wherein rofecoxib or a pharmaceutically acceptable salt thereof contains less than 0.10% 4-[4-(methylsulfinyl)phenyl]-3-phenyl-2(5H)-furanone. Composition. ヒト対象への経口、経鼻、吸入、局所、頬側、舌下、直腸、膣、および非経口の投与のうちの１つ以上に適している、請求項２３に記載の医薬組成物。 24. The pharmaceutical composition of claim 23, suitable for one or more of oral, nasal, inhalational, topical, buccal, sublingual, rectal, vaginal, and parenteral administration to a human subject. ヒト対象への経口投与に適している、請求項２８に記載の医薬組成物。 29. A pharmaceutical composition according to claim 28, suitable for oral administration to a human subject. ロフェコキシブまたはその薬学的に許容し得る塩が、１０～１２μｍのｄ９０粒子サイズ、３～４μｍのｄ５０粒子サイズ、および０．５～１．０μｍのｄ１０粒子サイズを有する、請求項２３に記載の医薬組成物。 24. The medicament of claim 23, wherein rofecoxib or a pharmaceutically acceptable salt thereof has a d90 particle size of 10-12 μm, a d50 particle size of 3-4 μm, and a d10 particle size of 0.5-1.0 μm. Composition. 対象の関節炎または片頭痛を処置するための医薬組成物であって、
医薬組成物が、１７．５ｍｇの高純度ロフェコキシブまたはその薬学的に許容し得る塩、および薬学的に許容し得る担体を含み、医薬組成物が、１日１回対象に投与するためのものであり、処置が、対象にオピオイド薬の使用の低減または中止をもたらし、高純度ロフェコキシブが、０．１０％未満の総不純物を含む、前記医薬組成物。 A pharmaceutical composition for treating arthritis or migraine in a subject, comprising:
A pharmaceutical composition comprises 17.5 mg of highly pure rofecoxib or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, and the pharmaceutical composition is for administration to a subject once a day. A, wherein the treatment results in a reduction or cessation of opioid drug use in the subject, and wherein the highly pure rofecoxib contains less than 0.10% total impurities. 高純度ロフェコキシブが、４－［４－（メチルスルホニル）フェニル］－３－フェニル－２，５－フランジオンを含まない、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition according to claim 31, wherein the high purity rofecoxib is free of 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2,5-furandione. 高純度ロフェコキシブが、０．１０％未満の４－［４－（メチルチオ）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition according to claim 31, wherein the high purity rofecoxib contains less than 0.10% 4-[4-(methylthio)phenyl]-3-phenyl-2(5H)-furanone. 高純度ロフェコキシブが、０．０５％未満の４－［４－（メチルチオ）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項３３に記載の医薬組成物。 34. The pharmaceutical composition according to claim 33, wherein the high purity rofecoxib contains less than 0.05% 4-[4-(methylthio)phenyl]-3-phenyl-2(5H)-furanone. 高純度ロフェコキシブが、０．０５％未満の４－［４－（メチルスルフィニル）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition according to claim 31, wherein the high purity rofecoxib contains less than 0.05% 4-[4-(methylsulfinyl)phenyl]-3-phenyl-2(5H)-furanone. 高純度ロフェコキシブが、０．０５％未満の４－［４－（メチルスルホニル）フェニル］－３－フェニル－５－ヒドロキシフラン－２－オンを含む、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition according to claim 31, wherein the high purity rofecoxib contains less than 0.05% 4-[4-(methylsulfonyl)phenyl]-3-phenyl-5-hydroxyfuran-2-one. 片頭痛が、フォン・ヴィレブランド病関連の片頭痛である、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein the migraine is von Willebrand's disease-associated migraine. 片頭痛が、前兆ありの片頭痛である、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein the migraine is migraine with aura. 片頭痛が、前兆なしの片頭痛である、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein the migraine is migraine without aura. 対象が、出血性障害を有し、医薬組成物が、因子補充療法と同時投与される、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of Claim 31, wherein the subject has a bleeding disorder and the pharmaceutical composition is co-administered with factor replacement therapy. 対象が、出血性障害を有しかつ因子補充療法を投与されているかまたは予防的に受けている、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein the subject has a bleeding disorder and is receiving or prophylactically receiving factor replacement therapy. 対象が、フォン・ヴィレブランド因子を通常より５０％低いレベルで発現する、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein the subject expresses von Willebrand factor at a level 50% lower than normal. 対象が、血友病ＡまたはＢと診断されている、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein the subject has been diagnosed with hemophilia A or B. 対象が、阻害剤の有無にかかわらず、第ＶＩＩＩ因子または第ＩＸ因子欠乏症を有する、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein the subject has a factor VIII or factor IX deficiency, with or without an inhibitor. 経口剤形である、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition according to claim 31, which is an oral dosage form. 固体経口剤形である、請求項４５に記載の医薬組成物。 46. The pharmaceutical composition according to claim 45, which is a solid oral dosage form. 固体経口剤形が、カプセル剤、錠剤、ピル、糖剤、粉末剤、または顆粒剤である、請求項４６に記載の医薬組成物。 47. The pharmaceutical composition of Claim 46, wherein the solid oral dosage form is a capsule, tablet, pill, dragee, powder, or granules. 液体経口剤形である、請求項４５に記載の医薬組成物。 46. The pharmaceutical composition according to claim 45, which is a liquid oral dosage form. 液体経口剤形が、乳剤、マイクロ乳剤、液剤、懸濁剤、シロップ剤、またはエリキシル剤である、請求項４８に記載の医薬組成物。 49. The pharmaceutical composition of Claim 48, wherein the liquid oral dosage form is an emulsion, microemulsion, solution, suspension, syrup, or elixir. 対象が、１２歳以上である、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of Claim 31, wherein the subject is 12 years of age or older. 対象が、１２歳から７５歳までである、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of Claim 31, wherein the subject is between the ages of 12 and 75. 処置が、疼痛強度数値評価尺度（Pain Intensity Numerical Rating Scale）においてベースラインから少なくとも１の低下を達成する、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein treatment achieves a reduction of at least 1 from baseline on the Pain Intensity Numerical Rating Scale. 処置が、疼痛強度数値評価尺度においてベースラインから少なくとも２の低下を達成する、請求項５２に記載の医薬組成物。 53. The pharmaceutical composition of Claim 52, wherein the treatment achieves a reduction of at least 2 from baseline on the Pain Intensity Numerical Scale. 処置が、疼痛強度数値評価尺度においてベースラインから少なくとも３の低下を達成する、請求項５３に記載の医薬組成物。 54. The pharmaceutical composition of Claim 53, wherein the treatment achieves a reduction of at least 3 from baseline on the Pain Intensity Numerical Scale. 処置が、疼痛強度数値評価尺度においてベースラインから少なくとも４の低下を達成する、請求項５４に記載の医薬組成物。 55. The pharmaceutical composition of claim 54, wherein the treatment achieves a reduction of at least 4 from baseline on the Pain Intensity Numerical Scale. 処置が、疼痛強度数値評価尺度においてベースラインから少なくとも５の低下を達成する、請求項５５に記載の医薬組成物。 56. The pharmaceutical composition of Claim 55, wherein the treatment achieves a reduction of at least 5 from baseline on the Pain Intensity Numerical Scale. 処置が、処置の開始前と比較して、対象に、処置の過程におけるアセトアミノフェンの使用の低減または中止をもたらす、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein treatment results in the subject reducing or discontinuing use of acetaminophen during the course of treatment compared to prior to initiation of treatment. 処置が、処置の開始前と比較して、対象に、処置の過程におけるオピオイド薬の使用の低減または中止をもたらす、請求項３１に記載の医薬組成物。 32. The pharmaceutical composition of claim 31, wherein treatment results in the subject reducing or discontinuing use of the opioid drug during the course of treatment compared to prior to initiation of treatment. 対象の疼痛、発熱、または炎症を処置するための医薬組成物であって、
医薬組成物が、１７．５ｍｇの高純度ロフェコキシブまたはその薬学的に許容し得る塩、および薬学的に許容し得る担体を含み、医薬組成物が、１日１回対象に投与するためのものであり、高純度ロフェコキシブが、０．１０％未満の総不純物を含む、前記医薬組成物。 A pharmaceutical composition for treating pain, fever, or inflammation in a subject, comprising:
A pharmaceutical composition comprises 17.5 mg of highly pure rofecoxib or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, and the pharmaceutical composition is for administration to a subject once a day. A, wherein the highly pure rofecoxib contains less than 0.10% total impurities. 高純度ロフェコキシブが、４－［４－（メチルスルホニル）フェニル］－３－フェニル－２，５－フランジオンを含まない、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of claim 59, wherein the high purity rofecoxib is free of 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2,5-furandione. 高純度ロフェコキシブが、０．１０％未満の４－［４－（メチルチオ）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of claim 59, wherein the high purity rofecoxib contains less than 0.10% 4-[4-(methylthio)phenyl]-3-phenyl-2(5H)-furanone. 高純度ロフェコキシブが、０．０５％未満の４－［４－（メチルチオ）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of claim 59, wherein the high purity rofecoxib contains less than 0.05% 4-[4-(methylthio)phenyl]-3-phenyl-2(5H)-furanone. 高純度ロフェコキシブが、０．０５％未満の４－［４－（メチルスルフィニル）フェニル］－３－フェニル－２（５Ｈ）－フラノンを含む、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of claim 59, wherein the high purity rofecoxib contains less than 0.05% 4-[4-(methylsulfinyl)phenyl]-3-phenyl-2(5H)-furanone. 高純度ロフェコキシブが、０．０５％未満の４－［４－（メチルスルホニル）フェニル］－３－フェニル－５－ヒドロキシフラン－２－オンを含む、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of claim 59, wherein the high purity rofecoxib contains less than 0.05% 4-[4-(methylsulfonyl)phenyl]-3-phenyl-5-hydroxyfuran-2-one. 経口剤形である、請求項５９に記載の医薬組成物。 60. A pharmaceutical composition according to claim 59, which is an oral dosage form. 固体経口剤形である、請求項６５に記載の医薬組成物。 66. The pharmaceutical composition according to claim 65, which is a solid oral dosage form. 固体経口剤形が、カプセル剤、錠剤、ピル、糖剤、粉末剤、または顆粒剤である、請求項６６に記載の医薬組成物。 67. The pharmaceutical composition of Claim 66, wherein the solid oral dosage form is a capsule, tablet, pill, dragee, powder, or granules. 液体経口剤形である、請求項６５に記載の医薬組成物。 66. The pharmaceutical composition according to claim 65, which is a liquid oral dosage form. 液体経口剤形が、乳剤、マイクロ乳剤、液剤、懸濁剤、シロップ剤、またはエリキシル剤である、請求項６８に記載の医薬組成物。 69. The pharmaceutical composition of Claim 68, wherein the liquid oral dosage form is an emulsion, microemulsion, solution, suspension, syrup, or elixir. 対象が、１２歳以上である、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of Claim 59, wherein the subject is 12 years of age or older. 対象が、１２歳から７５歳までである、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of Claim 59, wherein the subject is between the ages of 12 and 75. 対象が、重篤な心血管血栓性事象のリスクが低い対象集団内にある、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of claim 59, wherein the subject is within a low risk subject population for a serious cardiovascular thrombotic event. 対象が、心血管疾患の病歴または現在の症状を有さない、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of claim 59, wherein the subject has no history or current symptoms of cardiovascular disease. 対象が、出血性障害を有する、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of Claim 59, wherein the subject has a bleeding disorder. 疼痛、発熱、または炎症が、血友病性関節症、変形性関節症、リウマチ性関節炎、小関節型または多関節型若年性リウマチ性関節炎（ＪＲＡ）、若年性特発性関節炎、急性疼痛、原発性月経困難症、片頭痛発作、およびフォン・ヴィレブランド病関連の片頭痛からなる群から選択される１つ以上の状態によって引き起こされる、請求項５９に記載の医薬組成物。 Pain, fever, or inflammation associated with hemophilic arthritis, osteoarthritis, rheumatoid arthritis, small or polyarticular juvenile rheumatoid arthritis (JRA), juvenile idiopathic arthritis, acute pain, primary 60. The pharmaceutical composition of claim 59, caused by one or more conditions selected from the group consisting of dysmenorrhea, migraine attacks, and von Willebrand's disease-related migraine. 疼痛または炎症が、乾癬性関節炎または線維筋痛症によって引き起こされる、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of Claim 59, wherein the pain or inflammation is caused by psoriatic arthritis or fibromyalgia. 処置が、疼痛強度数値評価尺度（Pain Intensity Numerical Rating Scale）においてベースラインから少なくとも１の低下を達成する、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of claim 59, wherein treatment achieves a reduction of at least 1 from baseline on the Pain Intensity Numerical Rating Scale. 処置が、疼痛強度数値評価尺度においてベースラインから少なくとも２の低下を達成する、請求項７７に記載の医薬組成物。 78. The pharmaceutical composition of claim 77, wherein the treatment achieves a reduction of at least 2 from baseline on the Pain Intensity Numerical Scale. 処置が、疼痛強度数値評価尺度においてベースラインから少なくとも３の低下を達成する、請求項７８に記載の医薬組成物。 79. The pharmaceutical composition of Claim 78, wherein the treatment achieves a reduction of at least 3 from baseline on the Pain Intensity Numerical Scale. 処置が、疼痛強度数値評価尺度においてベースラインから少なくとも４の低下を達成する、請求項７９に記載の医薬組成物。 80. The pharmaceutical composition of Claim 79, wherein the treatment achieves a reduction of at least 4 from baseline on the Pain Intensity Numerical Scale. 処置が、疼痛強度数値評価尺度においてベースラインから少なくとも５の低下を達成する、請求項８０に記載の医薬組成物。 81. The pharmaceutical composition of claim 80, wherein treatment achieves a reduction of at least 5 from baseline on the Pain Intensity Numerical Scale. 処置が、処置の開始前と比較して、対象に、処置の過程におけるアセトアミノフェンおよび／またはオピオイド薬の使用の低減または中止をもたらす、請求項５９に記載の医薬組成物。 60. The pharmaceutical composition of claim 59, wherein treatment results in the subject reducing or discontinuing use of acetaminophen and/or opioid drugs during the course of treatment compared to prior to initiation of treatment. 疼痛、発熱、または炎症が、片頭痛発作によって引き起こされる、請求項７５に記載の医薬組成物。 76. The pharmaceutical composition of Claim 75, wherein the pain, fever, or inflammation is caused by a migraine attack.
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